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May 20, 2008 Meeting Minutes

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service
National Institutes of Health
John E. Fogarty International Center
for Advanced Study in the Health Sciences

Minutes of the Advisory Board
Sixty-ninth Meeting

 

Table of Contents


Closed Session

  1. Call to Order and Introductory Remarks
  2. Dates of Future Board Meetings
  3. Review of Requirements for Confidentiality
  4. Review of Applications
  5. Minutes of Previous Meeting
    1. Open Session
  6. Introduction
  7. Global Programs and Strategies: National Cancer Institute
  8. Global Programs and Strategies: National Heart, Lung, and Blood Institute
    1. Closed Session
  9. Adjournment

The John E. Fogarty International Center for Advanced Study in the Health Sciences (Fogarty) convened the sixty-ninth meeting of its Advisory Board on Tuesday, May 20, 2008, at 10:30 a.m., in the Conference Room of the Lawton Chiles International House, National Institutes of Health (NIH), Bethesda, Maryland. The closed session was held from 8:30 a.m. to 10:15 a.m. and from 1:30 p.m. to 3:00 p.m., as provided in Sections 552b(c) (4) and 552b(c) (6), Title 5, U.S. Code, and Section 10 (d) of Public Law 92-463, for the review, discussion, and evaluation of grant applications and related information.[1] The meeting was open to the public from 10:30 a.m. to 12:35 p.m. Dr. Roger I. Glass, Chair, Fogarty Advisory Board, and Director, Fogarty, presided. The Board roster follows the minutes of the meeting.

Board Members Present:


Dr. Elizabeth Barrett-Connor
Dr. Robert A. Black
Dr. Luz Claudio
Dr. Douglas C. Heimburger
Dr. Peter J. Hotez
Dr. Jim Yong Kim
Dr. Arthur Kleinman
Dr. Arthur Reingold
Dr. William A. Vega
Dr. Sten H. Vermund

Board Members Absent:


Dr. Karen H. Antman
Ting-Kai Li, M.D. (ex-officio)

Members of the Public Present:


Dr. Alejandro Cravioto
Director,
International Center for Diarrheal Disease
Research, Bangladesh
Dr. Peggy Kirkham
Purdue University,
West Lafayette, Indiana

Federal Employees Present:


Mr. Ira Allen, FIC/NIH
Dr. Ken Bridbord, FIC/NIH
Mr. Philip Budashewitz, NCI/NIH
Mr. Bruce Butrum, FIC/NIH
Ms. Elizabeth Cleveland, FIC/NIH
Mr. Robert Eiss, FIC/NIH
Dr. Dan Gerendasy, CSR.NIH
Dr. Roger I. Glass, FIC/NIH
Mr. Jeff Gray, FIC/NIH
Dr. John Haller, NIBIB/NIH
Dr. Karen J. Hoffman, FIC/NIH
Mr. Sean Jeffrey, FIC/NIH
Dr. Michael Johnson, FIC/NIH
Dr. Flora Katz, FIC/NIH
Dr. Richard Krause, FIC/NIH
Dr. Danuta Krotoski, NICHD/NIH
Dr. Vesna Kutlesic, OD/NIH
Dr. Yuan Liu, NINDS/NIH
Dr. Mike Martin, FIC/NIH
Ms. Alisa McCullar, FIC/NIH
Dr. Kathleen Michaels, FIC/NIH
Dr. Mark A. Miller, FIC/NIH
Dr. Peggy Murray, NIAAA/NIH
Ms. Sherri Park, NICHD/NIH
Dr. Aron Primack, FIC/NIH
Ms. Ann Puderbaugh, FIC/NIH
Dr. Josh Rosenthal, FIC/NIH
Ms. Angela Smith, FIC/NIH
Mr. Steve Smith, NIAID/NIH
Dr. Karl A. Western, NIAID/NIH
Ms. Sabrina Wilbern, FIC/NIH

CLOSED SESSION


I. CALL TO ORDER AND INTRODUCTORY REMARKS


Dr. Roger Glass, Director, Fogarty, called the meeting to order at 8:30 a.m. and welcomed Board members.

II. DATES OF FUTURE BOARD MEETINGS

Tuesday, September 9, 2008

Tuesday, February 10, 2009 Tuesday, May 19, 2009
Tuesday, September 8, 2009

III. REVIEW OF REQUIREMENTS FOR CONFIDENTIALITY

Mr. Robert Eiss reviewed the rules and regulations, which were maintained.

IV. REVIEW OF APPLICATIONS


Dr. Glass chaired the Closed Session review of applications, during which the Research Awards Working Group reported its activities. The Board concurred with the working group's recommendations for all applications. [2] The program actions are summarized below.

Ecology of Infectious Diseases (EID)
FIC Program Officer, Josh Rosenthal

This joint NIH-National Science Foundation (NSF) initiative supports efforts to understand the underlying ecological and biological mechanisms that govern relationships between human-induced environmental changes and the emergence and transmission of infectious diseases. The highly interdisciplinary research projects funded under this program apply to both ecological and biomedical methods, and study how environmental events such as habitat alteration, biological invasion, climate change, and pollution alter the risks of emergence and transmission of viral, parasitic, and bacterial diseases in humans and other animals. The program encourages consideration of how integrated environmental and biomedical approaches to infectious diseases may enhance our ability to predict and control them. The maximum total award size is $2.5 million, including indirect costs, and the maximum award duration is 5 years.

Fogarty staff brought three Fogarty-related applications to the Board

Fogarty International Research Collaboration Award (FIRCA)
Fogarty Program Officer, Kathleen Michels

This program provides funds ($32,000 per year in direct costs) to foster international research partnerships between NIH-supported U.S. scientists and their collaborators in developing countries. The FIRCA program aims to benefit the research interests of both U.S. and foreign collaborators while increasing research capacity at the foreign site. U.S. scientists who have an eligible NIH grant may apply. All areas of biomedical and behavioral research supported by NIH are eligible FIRCA research topics.

Fogarty received a total 51 applications of which 24 were triaged and 27 were not scored. Fogarty staff felt that the review of applications was appropriate. The working group approved the applications en bloc.

Framework Programs for Global Health
Fogarty Program Officer Flora Katz

The purpose of this initiative is to build global health research capacity in the United States and abroad. Under this program, institutions create administrative frameworks to bring together multiple schools (such as engineering, business, chemistry, biology, communication, public health, medicine, and environmental studies) to focus on global health and develop multidisciplinary global health curricula at undergraduate and graduate levels. Each program leverages and enhances currently funded global health projects at the institution supported by NIH and other sponsors as well as encourages new training opportunities, collaborations and research areas.

Framework awards provide up to 3 years of support. Two-year planning grants are offered in the first year of the award for developing- country institutions. The award uses the NIH Education Project grant (R25) mechanism.

Fogarty received a total 22 applications, of which 17 were triaged and 1 was not scored. Fogarty staff felt that the review of applications was appropriate. The working group approved the applications en bloc.

Global Infectious Disease Research Training Program (GID)
Fogarty Program Officer, Barbara Sina

Fogarty and the Centers for Disease Control and Prevention (CDC) developed this program to address research training needs related to infectious diseases that are predominantly endemic in or impact upon people living in developing countries. Previously, Fogarty supported several individual research-training programs through periodic Requests for Applications. Continuing programs include Actions for Building Capacity in Support of International Collaborations in Infectious Disease Research (ICIDR), Programs (ABC), and International Malaria Research Training (IMRT) Program. Fogarty has consolidated and standardized the requirements for all non-HIV/AIDS infectious disease research training programs under the GID Program Announcement.

Fogarty received a total of 18 applications, of which 4 applications were not scored. Fogarty staff felt that the review of applications was appropriate. The working group approved the applications en bloc.

Global Health Research Initiative Program for New Foreign Investigators (GRIP)
Fogarty Program Officer, Aron Primack

This program is intended to promote productive re-entry of NIH-trained foreign investigators into their home countries as part of a broader program to enhance the scientific research infrastructure in developing countries, stimulate research on a wide variety of high priority health-related issues in these countries, and advance NIH efforts to address health issues of global import. The specific goal of this initiative is to provide funding opportunities for the increasing pool of foreign biomedical and behavioral scientists, clinical investigators, nurses, and other health professionals on their return home with state-of-the-art knowledge of research methods to advance critical issues in global health. Upon completion of their research experiences under this mechanism, the developing-country participants are expected to continue to pursue independent and productive careers, including expert training and consultation and/or research on biomedical issues in their home institutions.

Study sections received 21 applications for this program, of which 11 were not scored. The working group approved the applications en bloc.

International Cooperative Biodiversity Groups (ICBG) - Limited Competition
Fogarty Program Officer, Josh Rosenthal

This program is a unique effort that addresses the interdependent issues of drug discovery, biodiversity conservation, and sustainable economic growth. Funding for the program is provided by six NIH components, NSF's Biological Sciences Directorate and the U.S. Department of Agriculture's Foreign Agriculture Service. The cooperating NIH components are Fogarty, National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA), and National Heart, Lung, and Blood Institute (NHLBI).

Fogarty received a total 20 applications, of which 4 were not scored. Fogarty staff felt that the review of applications was appropriate. The working group approved the applications en bloc.

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OPEN SESSION


V. Minutes of Previous Meeting


The minutes of the Fogarty Advisory Board meeting of February 5, 2008, were considered and approved unanimously.

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OPEN SESSION

VI. Introduction

Dr. Roger Glass, Director, Fogarty

Dr. Glass welcomed everyone. He said that the presentations in the open session would address the Fogarty aim to become more engaged with chronic diseases in global health and to forge new partnerships in doing so. This aim is the first strategic priority--expand Fogarty's investment in non-communicable disease research and research training--under Goal I (mobilize the scientific community to address the shifting global burden of disease and disability) in the new Fogarty strategic plan, Pathways to Global Health Research. Strategic Plan 2008-12.

Dr. Glass noted that issues in global health was the topic at the September 2007 NIH Directors Retreat. Organized by Dr. Glass and Dr. Anthony Fauci, Director, NIAID, the retreat highlighted the two major chronic diseases in developing countries and globally--cancer and cardiovascular disease.

VII. Global Programs and Strategies: National Cancer Institute

Dr. Anna Barker, Deputy Director, NCI

Dr. Barker described the emerging international burden of cancer, current opportunities for progress in this arena, NCI strategies for global investment, and NCI-Fogarty pilot programs. She emphasized that cancer is a major emerging international health issue and that, although the international basis of cancer is on the NCI agenda and NCI has fostered international research for many years, its efforts have lacked a strategic approach. It is in this regard that NCI now wishes to partner with Fogarty. The "drivers" for NCI's interest are the emerging international cancer burden, the progress in 21st century molecular and clinical sciences that depends on global partnerships, advances in technology and communication, and the possibility of delivering modern cancer medicine globally.

The Emerging International Burden of Cancer. The statistics on cancer in the developing world are staggering. In the United States, cancer continues to take nearly the same toll as it did in 1950 (190 deaths per 100,000 in 2003) and, in 2005, more than 650,000 Americans died of cancer. Globally, however, cancer could kill 10.3 million people each year by 2020, and since 2002, the percentage of deaths from cancer has increased 50 percent and more in most of the world (the Americas, Africa, Middle East, Asia, and the South Pacific). Countries with aging populations (e.g., China, Japan, United States) are already seeing increases in deaths from cancer, and the increase in the United States could be 30-40 percent in the next 15 years. Dr. Barker highlighted a particularly sobering reality--more than 70 percent of the people who died from cancer worldwide in 2005 were in low- and middle-income countries.

Opportunities for Progress. Dr. Barker stated that 21st century medicine will be predictive, pre-emptive, and personalized. And, as discussed in Science (May 26, 2006), the convergence of molecular sciences, advanced technologies, bioinformatics, and broadband capabilities is a unique opportunity for progress in health--in both industrialized and developing countries. Dr. Barker emphasized that the NCI "mantra" for developing countries, as for U.S. minority populations, is earlier identification and prevention of cancer.

As with opportunities, the barriers to progress are the same in industrialized and developing countries. They include, for example, the dearth of uniform procedures and standards, common high-quality reagents, common vocabularies and platforms for real-time sharing of information, and broad access to public databases. Additional barriers include lack of nonduplicative partnerships and networks, science-based regulatory pathways, and knowledge-based policy development. And, as Dr. Barker noted, each country presents specific cultural and policy challenges.

The NCI supports a series of advanced technology initiatives to address these needs. Key ones include the National Biospecimen Network, Alliance for Nanotechnology in Cancer, Clinical Proteomic Technologies Initiative, The Cancer Genome Atlas (TCGA), and the Cancer Biomedical Informatics Grid (caBIG™). Elaborating on the caBIG™ as a means to enable global cancer research, Dr. Barker said that this model of an open-source, open-access information network will enable researchers, clinicians, and patients do share data and knowledge on the discovery and delivery of new cancer interventions. Also, in 2006, NCI published the NCI First Generation Guidelines for Biorepositories. To address global opportunities inherent in genomics, NCI recently teamed with the National Human Genome Research Initiative (NHGRI) in launching the 3-year pilot TCGA to integrate a database of molecular and clinical information on the genetic basis of cancer and to determine the feasibility of developing a complete "atlas" of all genomic alterations involved in cancer. In nanotechnology, NCI is focusing on platforms that will enable new solutions in early detection, imaging, and therapy of cancer.

NCI's Strategies for Global Involvement. Dr. Barker commented that NCI's strategy for global involvement is fairly simple, but will be complex to implement. All of the opportunities for progress are, of course, global in nature. To address barriers, NCI intends to build on its historical strengths in international epidemiology, leverage its strong base of international investigator-to-investigator relationships, and coordinate NCI efforts more strategically through NCI's Office of International Affairs. It will undertake international partnerships in basic and clinical research and leverage new resources into international programs. Specifically, with Fogarty, NCI will develop pilot programs in selected geographic areas of high interest to NCI and, for the first time, will place NCI-supported investigators in-country.

NCI-Fogarty Pilot Program. Dr. Barker reviewed the rationale and status of two NCI-Fogarty pilot programs, in Latin America and China. In Latin America, NCI's Office for Cancer Programs is organizing a strategic plan for the pilot program and meeting with leaders in Brazil, China, and Mexico. The aim is to develop clinical trials networks, advanced technologies, and partnerships, including with philanthropies interested in this activity. Dr. Barker noted that the cancer burden in Latin America reflects U.S. trends, in which incidence rises as populations age. Further, cancers that can be prevented are prevalent (e.g., stomach cancer), and other (e.g., uterine and liver cancers) can be addressed with known approaches. She said that the increasing wealth in Latin America is being accompanied by a rise in science infrastructures with significant potential strengths for organizing and supporting clinical trials.

In China, NCI has posted a staff member in Beijing to coordinate ongoing NCI programs and to meet with senior cancer leaders across China. The planning of workshops and the development of a strategic plan are under way in three priority areas--molecular epidemiology, genomics, and clinical trial networks. The goal is to achieve longer-term posting of NCI staff in country. Dr. Barker noted that cancer is a major health care problem in China. More than 1.5 million Chinese die of cancer each year, more than one-third of the world's smokers reside in China, the country evinces unusual and unique environmental and dietary exposures, and unique cohorts present with rare cancers. Dr. Barker commented that NCI already has a strong epidemiological presence in China and that collaborating Chinese investigators are interested in forming new partnerships to address areas such as genomics and nanotechnology.

In closing, Dr. Barker suggested that, in the 21st century, knowledge and technology could enable physicians to "be anywhere". Globalization will drive synergy in medicine and health care to offer new standards of care and earlier detection and targeted interventions anywhere on the globe. Leadership in health and medicine will be distributed globally. The challenges to achieving synergy in global health care thus necessitate working across borders on issues such as informed consent, reducing redundancy of effort, balancing the need for public databases and patients' privacy, and managing intellectual property and conflicts of interest.

Discussion

The board noted several international research needs and discussed ongoing and potential NCI-Fogarty collaborations.

International Research Needs

Prevention Research. Dr. Reingold noted the enormous need for a future component on prevention in NCI's global strategies. Dr. Barker commented that NCI's approximately $5 billion budget includes a long history of prevention programs (e.g., tobacco control, cervical and infectious cancers, industrial exposures) in countries such as China and in Eastern Europe. She agreed that these programs need to be enabled further, for example in Latin America where gastric cancer, a preventable disease, is the largest killer in many countries.

Implementation Research. Dr. Black asked whether implementation research is a priority for NCI. He noted that delivery of interventions is a major issue in developing countries and that Fogarty has emphasized this research as an important strategy in its new Strategic Plan. Dr. Barker noted that NCI has clinical trials ongoing in many countries and is trying to develop networks and infrastructures for trials in countries that may not have robust infrastructures such as those in China and India, for example. Commenting that NCI has worked for years in countries to develop technologies that can stand up under field conditions, she noted that today's advanced technologies are driving exponential changes in the development of "leap-frog" technologies (e.g., telemetry) that could be available in the next 10 years for international needs in health care.

Creating a Coordinated In-country Presence. Dr. Barker agreed with Dr. Vermund about the need to create a "real" (not fragmented) U.S. research presence in countries by coordinating among activities supported by different NIH institutes or agencies (e.g., CDC, Food and Drug Administration). Dr. Barker cited on one example in which the U.S. embassy in China is creating space in the embassy to help unify U.S.-supported cancer research programs in that country.

NCI-Fogarty Collaboration

Dr. Glass encouraged discussion of potential NCI-Fogarty collaborations and how best to use available resources for global action against chronic diseases. He noted that, outside Sub-Saharan Africa, NCI has the largest investment overseas in funding and projects, of all NIH institutes and centers. Dr. Kenneth Bridbord, Director, Division of International Training and Research (DITR), commented that NCI is the single most significant collaborator, based on co-funding, in a variety of Fogarty programs. On behalf of Fogarty, he thanked NCI for its support of Fogarty programs. Dr. Barker extended her appreciation for Dr. Glass's leadership at Fogarty and thanked the entire Fogarty staff. She noted that the Fogarty Strategic Plan helps NCI think more aggressively about its activities in chronic disease, including development of pilot efforts in developing countries.

Supplemental Grants for Research Training. Dr. Vermund praised NCI and Fogarty for their collaboration in supporting supplemental grants to Fogarty trainees to expand their training into cancer research. He noted that these grants are a creative way to accelerate the magnitude of cancer research through research training and the building of partnerships and infrastructure. Dr. Barker noted that Fogarty excels at training and the NCI is very pleased with its co-funding investment. In her words, the collaboration has been "fabulous" and enables NCI to link in meaningful ways with former NCI trainees in many countries. She anticipated that NCI would continue to increase its support in this collaboration. Dr. Glass said that the NCI-Fogarty collaboration will help to foster "baptismal" experiences in cancer research overseas for U.S. investigators. In China, it will help to stimulate partnerships with many Chinese investigators who have returned home since receiving training at the NIH or other U.S. institutions.

Bioethics and Bioinformatics. Training in bioethics and bioinformatics are two areas in which Fogarty offers special expertise internationally for collaboration with NCI and other NIH institutes and centers. Dr. Reingold asked whether NCI has any plans to hold workshops or otherwise address the critical bioethical challenges in clinical research and treatment overseas (e.g., establishment of institutional review boards, IRBs). Dr. Barker noted that, whereas NCI has been engaged in these activities for many years (e.g., in Mexico), more emphasis and standardization are needed and activities will vary from country to country.

Elaborating on bioethics training, Dr. Karen Hofman, Director, Division of International Science Policy, Planning and Evaluation, Fogarty, said that the Fogarty program (the International Research Ethics Education and Curriculum Development Award) has been under way for approximately 7 years and has trained many individuals worldwide. Though not defined geographically, the program has included promotion of bioethics training in China. Dr. Hofman suggested that NCI and Fogarty may wish to consider building on this effort. Dr. Barker noted that the NCI Clinical Trials Cooperative Groups are presently developing an international ethics training program for NCI's 1,400+ clinical trial sites in China and that input from Fogarty bioethics staff would be very valuable.

Elaborating on bioinformatics training, Dr. Flora Katz, Program Officer, DITR, Fogarty, said that Fogarty has supported the Informatics Training for Global Health program for the past 9 years. The intent is to help develop the necessary informatics infrastructure needed for research in developing countries (e.g., for clinical trials). Previously, this very successful program did not include informatics training in China, but this opportunity may evolve as Fogarty soon seeks another round of applications.

Tobacco Control. Drs. Aron Primack and Xinghzhu LiuShu, Program Officers, DITR, said that Fogarty initiated, with significant NCI support, the International Tobacco and Health Research and Capacity Building Program (TOBAC) almost 7 years ago. This program, now in its second 5-year iteration, is an effective hybrid of research and training. Dr. Primack said that Fogarty still has a role to play in research on tobacco use and control, as tobacco use remains the leading risk factor for most deaths worldwide, and that support for the Fogarty program should be increased substantially. Fogarty is collaborating with NCI to plan a network meeting on themes in tobacco control. It also has teamed with NCI and NIMH to issue a Request for Applications for TOBAC to foster dissemination and implementation science in tobacco control. Dr. Barker commented that NCI is spending a large amount of its budget and effort on cancers related to tobacco use, but fighting the "marketing machine" for tobacco and changing people's behavior are not easy.

Rare Cancers in Developing Countries. Dr. Hotez suggested that NCI and Fogarty could interface in addressing unique cancers that occur exclusively in developing countries, for example bile duct or bladder cancers caused by parasites. Dr. Barker noted that, in the past few years, NCI investigators have isolated the causes of approximately 10 parasitic cancers. She suggested that research on such cancers could elucidate the biology of cancer in general and would best be done in-country so as to fully understand the disease process and the potential for prevention and treatment.

Institutional Partnerships in Centers of Excellence

Dr. Glass introduced Dr. Alejandro Cravioto, Director, International Center for Diarrheal Disease Research (ICDDR), Bangladesh. Dr. Cravioto described ICDDR--a model center of excellence for training and research in developing countries, which began with NIH support.

Dr. Cravioto reported that ICDDR has grown to be much more than a center for research in diarrheal diseases. Over the past 15 years, it has developed from a single-focused entity into a center for public health research ranging across diseases (e.g., infectious and respiratory diseases, malaria, HIV/AIDS) as well as health and social problems (e.g., maternal and child health, violence, empowerment of women, poverty). Dr. Cravioto noted that the Government of the People's Republic of Bangladesh chartered ICDDR as an independent organization fully accountable for its budget and open to research collaborations worldwide. He noted further that ICDDR collaborates with NIH on a number of projects. For example, after deciding in 2007 to extend its effort to chronic diseases, ICDDR received initial co-funding through the NHLBI-Ovations Chronic Disease Initiative. ICDDR hopes to identify additional sources of funding to support research of common interest to both sides of the Pacific.

Dr. Vermund commented that ICDDR has a remarkable independence and multinational/multi-institutional capacity in staff and partners that is not often seen elsewhere. He encouraged NIH and Fogarty to create incentives that would promote a similar multifaceted (rather than single-focus) approach to establishing centers of excellence. This approach, which could involve networks of institutions within countries, would yield much more sustainable (i.e., successful) centers.

In discussion, Dr. Cravioto reported that, of ICDDR's annual budget of approximately $30 million, 40 percent (i.e., core, restricted funds) comes from 3-year contracts awarded by development agencies, while 60 percent comes from competitively awarded grants obtained by ICDDR investigators worldwide. He noted that the center hopes to develop other mutual, respectful relationships similar to its longstanding and highly beneficial collaboration with Johns Hopkins University. In its own strategic planning, ICDDR considered whether to broaden or focus its areas of interest. It recognized the need to address a major concern for Bangladesh--that is, its aging population and the increase in chronic diseases (e.g., diabetes, heart disease) that is likely to occur.

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VIII. Global Programs and Strategies: National Heart, Lung, and Blood Institute

Elizabeth Nabel, Director, NHLBI

Dr. Nabel spoke about cardiovascular diseases in developing countries and new NHLBI initiatives in global health. Cardiovascular disease is the number one killer worldwide and is increasingly prevalent in low- and middle-income countries, as in high-income countries. Pulmonary diseases and some blood diseases (e.g., sickle cell disease) are significant chronic diseases as well. Dr. Nabel reported that, in 2007, NHLBI supported research in 44 countries. Whereas most of this support was for research in high-income countries, NHLBI is increasing its research support in low- and middle-income countries. The NHLBI funds both U.S. investigators with trial sites overseas and principal investigators in other countries.

Dr. Nabel said that the NHLBI Strategic Plan: Shaping the Future of Research, completed in 2006, articulates a vision for providing global leadership in research and education on heart, lung, and blood diseases and blood resources to enhance the health of individuals. Following on this plan, in November 2007, NHLBI convened an NHLBI Global Cardiovascular Health Advisory Group to advise the institute on how best to leverage in investments in partnership with others to have an impact on the global cardiovascular health community. Drs. Glass and Kim are members of the advisory group.

Dr. Nabel noted that, based on the group's recommendations, the NHLBI decided to focus on five areas in which to leverage its resources strategically and creatively. The five areas of support are for (i) an NHLBI-Ovations Chronic Disease Initiative; (ii) pre- and postdoctoral fellowships for Ovations participants, to be funded initially through the NIH/Fogarty Clinical Research Training Scholars and Fellows Program; (iii) discussions of the Oxford Health Alliance's grand challenges and, specifically, six goals in chronic disease (as articulated in Nature, 22 November 2007); (iv) an Institute of Medicine (IOM) study, entitled "Preventing the Global Epidemic of Cardiovascular Disease, Meeting the Challenges in Developing Countries," to better understand the global epidemic of cardiovascular disease; and (v) an NHLBI-World Health Organization (WHO) Partnership in Chronic Pulmonary Disease. Dr. Nabel mentioned that NHLBI also will continue its longstanding relations with WHO in pulmonary disease areas (e.g., asthma, chronic obstructive pulmonary disease, smoking) and plans to expand longstanding programs in sickle cell disease.

Elaborating on the Ovations initiative, Dr. Nabel said that NHLBI is partnering with Ovations, one of five businesses operated by UnitedHealth Group, the largest health insurer in the United States. Dr. Nabel noted that this partnership stems from Fogarty and NHLBI participation in reviewing more than 160 applications received by Ovations in response to its request for applications to develop a series of chronic disease centers of excellence worldwide. The NHLBI initiative, soon to be announced, will fund eight centers (in 11 locations), beginning in January 2009, to focus on primary and secondary prevention of cardiovascular disease, screening and detection of risk factors, and possibly, treatment modalities. The centers, in low- and middle-income countries, will partner with academic institutions (e.g., schools of public health) in industrialized countries. Dr. Nabel noted that the first meeting of site investigators was in February 2008 and that subsequent meetings will be "piggybacked" onto the annual meeting of the Oxford Health Alliance. In discussion later, Dr. Nabel commented that the Alliance and Ovations activities have common objectives and substantial overlap in the participants.

Elaborating on the NHLBI-WHO partnership, Dr. Nabel said that, in April 2008, NHLBI staff met extensively and productively with the director and staff of WHO's Non-Communicable Disease Cluster. Together, the organizations decided to focus on two areas: (a) integration of guidelines for primary and secondary prevention that are tailored to six world regions and can serve as a Web- and evidence-based tool, to be updated regionally, and (b) discussions of mutually beneficial research programs.

Discussion

The Board members addressed the Ovations initiative, the emergence of a global agenda in chronic diseases, and specific research needs.

NHLBI-Ovations Chronic Disease Initiative

Dr. Vermund applauded NHLBI for making a tremendous investment in the Ovations effort. Dr. Glass said that the joint initiative could be a model for fostering U.S. participation in global health if one of the outcomes is U.S. investigators' expanded interest in international research on global health. He thanked Dr. Nabel for her collaboration with Fogarty and her leadership in developing the partnership with Ovations. Dr. Nabel thanked Dr. Glass for being the essential catalyst for the effort.

Dr. Glass asked Dr. Cravioto to share his perspective as director of one of the right Ovations centers that NHLBI will co-fund. Dr. Cravioto mentioned two research activities on ICDDR's agenda. One is to expand study of a cohort in rural Bangladesh that researchers have been following for three generations to determine whether early life experiences can affect markers later in life. The second is to conduct research tailored to problems in Bangladesh, in partnership with others who have special expertise in chronic diseases. He welcomed the NHLBI participation in Ovations, as it offers ICDDR an opportunity to apply for and obtain additional funds for research.

Dr. Nabel mentioned that NHLBI intends to convene a meeting of the principal investigators in fall 2008 to establish "metrics" for the 1st year and to acquaint the investigators with research activities and colleagues in other centers. The aim is to promote synergy among the centers and to stimulate U.S. investigators to identify potential research collaborations.

Dr. Claudio asked whether other private insurance companies could partner in the initiative. Dr. Nabel noted that the partnership with Ovations, which will be established through a 5-year Memorandum of Understanding, is a new and interesting model of research support for NHLBI.

Global Agenda in Chronic Diseases

Dr. Glass commented that his interest in promoting an agenda for international research in chronic diseases arose from the Disease Control Priorities Project (DCPP), which documented the burden of cardiovascular (and other) diseases worldwide and possible approaches for addressing this burden. He noted that some of the approaches have yet to be tested fully, but may be appropriate for both developing and industrialized countries. He quoted Dr. Elias Zerhouni, Director, NIH as saying, when learning that cardiovascular disease is the number one killer in developing countries, "my entire budget in NIH is a global health budget."

Dr. Kim noted that a number of different international meetings are being convened to address global health initiatives and the strengthening of health care delivery systems in developing countries. He urged NIH and Fogarty to participate in these meetings to shape the discussions and to ensure that cancer, cardiovascular, and other non-communicable diseases are at the center of the health systems being envisaged. Dr. Nabel remarked that NHLBI is eager to participate in and contribute to these conversations as an advocate for cardiovascular disease and the funding of implementation research.

Specific Research Needs

Dr. Glass asked Dr. Nabel to comment on where NHLBI "would like to be" in 5 years in terms of international research. She said that she would like NHLBI to have remained focused and to have successfully accomplished the five activities she outlined in her presentation, while not creating a perception that, during tight budget times, NHBLI had shipped too many resources overseas and, yet, continuing to support U.S. grantees interested in developing research collaborations with overseas partners. Success would include, for example, achieving a list of measured outcomes through the NHLBI-Ovations Chronic Disease Initiative, completion of the IOM update on the global cardiovascular disease epidemic, and having trained a dozen cardiovascular scientists interested in global cardiovascular health.

Linking Infectious Diseases with Chronic Diseases. Dr. Hotez noted the connection between chronic infectious and non-communicable diseases and the need to look at endpoint pathways (e.g., anemia) that may reflect many different causes. Commenting that the Bill and Melinda Gates Foundation is considering creation of a cross-disciplinary "gut health" program, he suggested that Fogarty could play an important role in linking institute initiatives across NIH (e.g., NHLBI and NIAID).

Linking the Epidemiological Factors in Cardiovascular Disease. Dr. Bartlett-Connor expanded on Dr. Hotez' comment about the need to link activities across NIH "silos" by naming two other examples--diabetes and obesity, two key factors in the potential continued increase of cardiovascular disease in developing countries. In addition, she encouraged NHLBI to link up with the World Heart Foundation's annual 10-day annual epidemiology international seminar, which trains epidemiologists, including many who specialize in cardiology, in developing countries. Dr. Nabel said that she was pleased to learn about the seminar and that many NHLBI-Ovations centers will include studies of obesity and diabetes, as part of the melange of factors contributing to cardiovascular disease.

Long-term Cohort Studies. Dr. Black said, as well, that fetal and early childhood insults (e.g., undernutrition) may have major long-term and permanent consequences for development of diabetes and cardiovascular or lung disease. Noting that the short-term nature of most NIH funding is a major research limitation, he encouraged NHLBI and Fogarty to fund, directly or in partnership with others, long-term cohort studies, either observational or interventional, that begin in early life and childhood. Dr. Nabel commented that NHLBI has funded longitudinal cohort studies for decades and would consider supporting a well-designed study if proposed by one of the Ovations centers.

Disease Effects of Air Pollution. Dr. Josh Rosenthal, Deputy Director, DITR, asked whether NHLBI has considered addressing indoor air pollution (e.g., from fuel- and wood-burning cooking), one of the largest contributors to the growing burden of disease (e.g., chronic obstructive pulmonary disease) in developing countries. Dr. Nabel commented that NHLBI has no major research effort in this area. She added that NHLBI will continue to work on issues of smoking in collaboration with other organizations, but is not likely to initiate or lead programs in this area.

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Closed Session

During the second part of the closed session, the Board heard and discussed a report on the FIRCA program, the report of the Fogarty director, and a report on the Fogarty Global Health Leaders Consultation, held April 28-30, 2008.

IX. Adjournment

The meeting was adjourned at 3:00 p.m. on May 20, 2008.

Abbreviations Used in the Minutes



ABC

Actions for Building Capacity in Support of International Collaborations in Infectious Diseases Research (ICIDR) Programs
AIDS
Acquired Immunodeficiency Syndrome
caBIG™
Cancer Biomedical Informatics Grid
CDC
Centers for Disease Control and Prevention
CSR
Center for Scientific Review
DCPP
Disease Control Priorities Project
DITR
Division of International Training and Research
EID
Ecology of Infectious Diseases
Fogarty/FIC
John E. Fogarty International Center for Advanced Study in the Health Sciences
FIRCA
Fogarty International Research Collaboration Award
GID
Global Infectious Disease Research Training Program
GRIP
Global Health Research Initiative Program for New Foreign Investigators
HIV
Human immunodeficiency virus
ICBG
International Cooperative Biodiversity Groups
ICDDR
International Center for Diarrheal Disease Research
IMRT
International Malaria Research Training
IOM
Institute of Medicine
IRBs
Institutional Review Boards
NCI
National Cancer Institute
NHLBI
National Heart, Lung, and Blood Institute
NIAAA
National Institute on Alcohol Abuse and Alcoholism
NIAID
National Institute of Allergy and Infectious Diseases
NIBIB
National Institute of Biomedical Imaging and Bioengineering
NICHD
Eunice Kennedy Shriver National Institute of Child Health and Human Development
NIDA
National Institute on Drug Abuse
NIH
National Institutes of Health
NIMH
National Institute of Mental Health
NINDS
National Institute of Neurological Disorders and Stroke
NSF
National Science Foundation
OD
Office of the Director
TCGA
The Cancer Genome Atlas
TOBAC
International Tobacco and Health Research and Capacity Building Program
WHO
World Health Organization


Fogarty International Center Advisory Board Roster

(All terms end January 31)

February 2008

Roger I. Glass, M.D., Ph.D. (Chair)

Director, Fogarty International Center for Advanced Study in the Health Sciences and Associate Director for International Research,
National Institutes of Health

Douglas C. Heimburger, M.D., M.S. (2008*)

Professor, Division of Clinical Nutrition & Dietetics
Departments of Nutrition Sciences and Medicine
University of Alabama at Birmingham

William A. Vega, Ph.D. (2009)

Professor of Family Medicine
Department of Family Medicine
David Geffen School of Medicine at UCLA

Karen H. Antman, M.D. (2010)

Provost and Dean
Boston University School of Medicine

Peter Hotez, M.D., Ph.D. (2011)

Professor and Chair
Department of Microbiology and Tropical Medicine
George Washington University & Sabin Vaccine Institute

Sten H. Vermund, M.D., Ph.D. (2011)

Director, Institute for Global Health
Professor of Pediatrics, Medicine, Preventive Medicine and Obstetrics and Gynecology
Vanderbilt University Medical Center

Elizabeth Barrett-Connor, M.D. (2008*)

Professor and Division Chief
Division of Epidemiology
Department of Family and Preventive Medicine
University of California, San Diego

Jim Yong Kim, M.D., Ph.D. (2011)

Head, Department of Social Medicine
Associate Clinical Professor of Social Medicine
Brigham and Women's Hospital
Harvard School of Public Health

Robert Black, M.D., M.P.H. (2011)

Department of International Health
The Johns Hopkins University
Bloomberg School of Public Health


Arthur Kleinman, M.D., M.A. (2009)

Esther and Sidney Rabb Professor and Chair
Department of Anthropology
Harvard University

Luz Claudio, Ph.D. (2010)

Associate Professor
Department of Community and Preventive Medicine
Mount Sinai School of Medicine

Arthur Reingold, M.D. (2011)

Professor and Chair, Division of Epidemiology
Center for Infectious Disease Preparedness
UC Berkeley School of Public Health

EX-OFFICIO Member

Ting-Kai Li, M.D. (2010)

Director
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, Bethesda, MD

 

EXECUTIVE SECRETARY

Robert Eiss

Office of the Director
Fogarty International Center
National Institutes of Health
Bethesda, MD

 

*term extended to July 2008


[1] Members absent themselves from the meeting when the Board discusses applications from their own institutions or when a conflict of interest might occur. The procedure applies only to individual applications discussed, not to en bloc actions.

[2] Applications that were noncompetitive, unscored, or not recommended for further consideration by initial review groups were not considered by the Board.


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